School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes (NCT06420661) | Clinical Trial Compass
By InvitationNot Applicable
School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes
United States30 participantsStarted 2024-08-21
Plain-language summary
This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of type 1 diabetes for at least 6 months
* Attend school in one of the partnered school districts
* Receive daily oversight from the school nurse for their diabetes
* Managed by the Children's Hospital of Pittsburgh Diabetes center
* Able to participate in English
Exclusion Criteria:
* Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
* Child is completely independent in diabetes care in school
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is enrolling by invitation only, can you find out if our school or care team is already partnered with this program, and whether my child might be considered for it?
2This study is measuring 'feasibility,' which suggests researchers are still figuring out whether this kind of school-based collaborative care approach can actually work in practice — so what does that mean for what my child would experience, and how much is already known about whether it helps kids manage Type 1 diabetes?
3The intervention seems to involve coordination between our healthcare team and my child's school — how realistic is that kind of collaboration given our school's resources, and would it create extra demands on us as a family?
4Since this isn't a traditional drug or device trial and has no listed phase, how does this differ from standard diabetes care and support my child already receives, and could pursuing standard care options first make more sense right now?
5If my child were involved in this study, who would we be working with day-to-day — school staff, diabetes care providers, or both — and how would that be coordinated to make sure nothing falls through the cracks?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.